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# bB BioChem Warned on CGMP Violations
- URL: https://www.fdaweb.com/bb-biochem-warned-on-cgmp-violations/
- Published: 2018-07-17T12:00:00.000Z
- Updated: 2026-09-15T00:19:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141895

A 12/12-12/18/17 FDA inspection at bB BioChem Laboratories, Santa Ana, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/3 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm613546.htm?ref=fdaweb.com) says the inspection also revealed that the firm manufactures unapproved new drug products. Specific violations noted were: 

- failing to have, for 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;
- failing to conduct at least one test to verify the identity of each component of a drug product, and also failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
- failing to ensure that the drug product bore an expiration date that was supported by appropriate stability testing; and
- failing to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA strongly recommended that the company retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It says the consultant should also perform a comprehensive audit of the company’s entire operation for CGMP compliance and evaluate the completion and effectiveness of any corrective and preventive actions it has implemented.

The letter says that two of the firm’s products do not comply with the tentative final monograph for external analgesic drug products for over-the-counter human use. It says the products are legally considered to be unapproved new drugs and the marketing of them violates the Federal Food, Drug, and Cosmetic Act.

bB BioChem was told to respond with a list of specific steps taken since the inspection to control the violations and prevent their recurrence, with a timetable for completion.