USFDA 483 Warning Letter Dated MARCH 30, 2022

USFDA 483 Warning Letter Dated MARCH 30, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do … Read more

USFDA 483 Warning Letter Dated MAY 23, 2022

USFDA 483 Warning Letter Dated MAY 23, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do … Read more

USFDA 483 Warning Letter Dated JUNE 14, 2022

USFDA 483 Warning Letter Dated JUNE 14, 2022 1. Failure to perform repackaging of API under appropriate CGMP to avoid potential cross-contamination. During your API repackaging and relabeling operations, including highly potent drugs such as testosterone, estradiol, betamethasone, tamoxifen, and opioids, your firm failed to conduct adequate cleaning validation studies to demonstrate that your cleaning … Read more

USFDA 483 Warning Letter Dated JUNE 10, 2022

USFDA 483 Warning Letter Dated JUNE 10, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals 1. The company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch … Read more

USFDA 483 Warning Letter Dated JUNE 22, 2022

USFDA 483 Warning Letter Dated JUNE 22, 2022 1. Each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)) and the company failed to prove this procedure. The company manufactured an OTC … Read more

USFDA 483 Observations – Top 5 Common Observations

USFDA 483 Observations – Top 5 Common Observations Quality control procedures not in writing fully followed Scientifically sound laboratory controls not established Investigations of discrepancies, failures to adequately review Absence of Written Procedures for production and process controls Written procedures not established/followed for cleaning and maintenance equipment Lack of or inadequate procedures (CAPAs) Lack of … Read more

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