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# Pharmaceutical Laboratories and Consultants Warned
- URL: https://www.fdaweb.com/pharmaceutical-laboratories-and-consultants-warned/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142381

A 9/18-10/10/17 FDA inspection at Pharmaceutical Laboratories and Consultants, Addison, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the contract testing laboratory. A just-released 8/29 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620002.htm?ref=fdaweb.com) says similar deficiencies were cited in 2007, 2009, 2012, and 2014 inspections to which the company failed to respond. No response has been received with corrective actions for the violations identified in the latest inspection, the letter says.

“These repeated failures demonstrate that management oversight and control over the testing of over-the-counter drugs and components is inadequate,” the letter says. Specific violations in the letter were: 

- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions;
- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance; and
- failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The letter says FDA considers contractors as extensions of a manufacturer’s own facility and thus must meet CGMP requirements. “Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements,” FDA says.

The agency also say that because the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures, it should respond with **(1)** a comprehensive investigation into the extent of inaccuracies in data, records, and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the company’s drug; and **(3)** a company management strategy that includes details of its global corrective and preventive action plan.

The inspection also determined the company is operating a microbrewery in a space shared with the contract testing laboratory where OTC drugs are tested. “You prepared and stored microbiology laboratory media in the same area you use to conduct brewery operations,” FDA says. “These facility conditions pose unacceptable risks, including contamination of media during its preparation and compromised sample analyses. Conducting your testing operations in a spaced shared with a microbrewery is inappropriate and does not comply with CGMP. Your testing must be performed using facilities that are designed and controlled for drug laboratory testing.”

The firm was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion. It also was told to contact FDA within five days of receipt of the Warning Letter to schedule a regulatory meeting to discuss the violations and the corrective and preventive actions the firm needs to implement.