(a) You must make and keep the records required under this subpart O in accordance with subpart P of this part. (b) You must make and keep the following records: (1) Written procedures for fulfilling the requirements of this subpart, (2) A written record of every product complaint that is related to good manufacturing practice, (i

As appropriate to the nature of the mitigation strategy and its role in the facility's food defense system: (a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for food defense monitoring of the mitigation strategies. (b) Food defense monitoring

North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984

., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. [42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19, 1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12

frozen. (b) The name of the food is “orange juice”. The name “orange juice” may be preceded on the label by the varietal name of the oranges used, and if the oranges grew in a single State, the name of such State may be included in the name, as for example, “California Valencia orange juice”. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992]

to be filled in with the name of the starch; for example, “Dried corn sirup”, “Corn sirup solids”, “Dried wheat sirup”, “Wheat sirup solids”, “Dried tapioca sirup”, “Tapioca sirup solids”. When the starch is derived from sorghum grain, the alternative name of the food is “Dried sorghum grain sirup” or “Sorghum grain sirup solids”. The word “sirup” may also be spelled “syrup”.

5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability

ingredient is used as a formulation aid, as defined in §170.3(o)(14) of this chapter. (2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice. [60 FR 63621, Dec. 12, 1995]

identified problems to prevent recurrence of a nonconforming product or other quality problem. (d) Reprocessing. If appropriate, you may reprocess a batch of a PET drug product that does not conform to specifications. If material that does not meet acceptance criteria is reprocessed, you must follow procedures stated in the product's approved application and the finished product must conform to specifications, except for sterility

The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in §341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride.

The active ingredients of the product consist of any of the following, within the established concentrations for each ingredient: (a) Cellulose derivatives: (1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent. (2) Hydroxyethyl cellulose, 0.2 to 2.5 percent. (3) Hypromellose, 0.2 to 2.5 percent.

As appropriate to the nature of the preventive control and its role in the facility's food safety system you must: (a) Establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls; and (b) Monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

(2) Indications for use. As an anti-inflammatory and analgesic agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014]

dogs and cats—(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours. (2) Indications for use. Treatment of respiratory, urogenital, skin, and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium. (3) Limitations. Federal law restricts this drug

(a) [Reserved] (b) Tolerances. The tolerances for penicillin are: (1) Cattle. (i) Edible tissues (excluding milk): 0.05 ppm. (ii) Milk: Zero. (2) Chickens. Edible tissues: Zero.

(a) [Reserved] (b) Tolerances. The tolerances for tylosin are: (1) Cattle. (i) Liver, kidney, fat, and muscle: 0.2 ppm. (ii) Milk: 0.05 ppm. (2) Chickens and turkeys.

, if applicable; (k) The patient followup plan, if applicable; (l) The procedures for monitoring conduct and progress of the surveillance; (m) An estimate of the duration of surveillance; (n) All data analyses and statistical tests planned; (o) The content and timing of reports.

§866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See §866.1(e) for the availability of this guidance document. [76 FR 14274, Mar. 9, 2012, as amended at

approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before April 21, 1997, for any endodontic dry heat sterilizer that was in commercial distribution

cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear. (b) Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is

) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976

(a) Identification. An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (

. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of

(a) Identification. An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the body. The device may include a holder that keeps the bag in place against an external area of the patient. (b) Classification. Class I (general controls). The device

(a) Identification. A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in

Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the

For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if: (a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;

produced, and the approximate number of such product units which have left the place of manufacture; (c) The expected usage for the product if known to the manufacturer; (d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; (e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal

Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate. (c) In-house reagents. You must validate and/or verify the processes used for production of in-house reagents. (d) Records. You must maintain the following records pertaining to supplies and reagents: (1) Records

(a) The Administrator shall exempt from payment of an application fee for registration or reregistration: (1) Any hospital or other institution which is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps., Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof. (2) Any individual practitioner who is required to obtain an