FDA establishment 1017175, Greensboro, North Carolina, United States. Part of Procter & Gamble Manufacturing Co.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.115(a). Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.194(a)(1). Description and Identification of Samples Laboratory records are deficient in that they do not include a quantity, date sample taken and date sample received for testing.
Official Action Indicated (OAI)
Mar 10, 2023
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not documented at the time of performance.
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
Voluntary Action Indicated (VAI)
Nov 17, 2017
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Voluntary Action Indicated (VAI)
May 6, 2016
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jul 18, 2013
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.194(d). Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Voluntary Action Indicated (VAI)
Feb 5, 2010
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
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