The U.S. Food and Drug Administration (FDA) has inspected drug
manufacturing facility, Bicooya Cosmetics Limited at No. 17, Yan Hu Road,
Shangxi Town, Zhejiang, from May 22–25, 2017.
This warning letter summarizes significant violations of current
good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
See 21 CFR, parts 210 and 211.
During our inspection, FDA investigator observed specific
violations including, but not limited to, the following.
1. Your firm failed to keep the buildings
used in the manufacture, processing, packing, or holding of a drug product free
of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).
Investigator observed rodent feces throughout your facility:
·
in direct proximity to the filling machine where you manufacture
OTC drug products
·
in direct proximity to the (b)(4) system, which
produces (b)(4) incorporated in your drug products
·
throughout the warehouse, around both raw materials and finished
drug products
Your over-the-counter (OTC) drug products include (b)(4) ointments
and (b)(4).
2. Your firm failed to clean, maintain, and,
as appropriate for the nature of the drug, sanitize and/or sterilize equipment
and utensils at appropriate intervals to prevent malfunctions or contamination
that would alter the safety, identity, strength, quality, or purity of the drug
product beyond the official or other established requirements (21 CFR
211.67(a)).
For example, our investigator observed residue build-up in
the (b)(4) tanks you use to manufacture OTC drug products, and
damaged transfer hoses held together with plastic wrap. When an employee
attempted to open a (b)(4) tank lid during the inspection, a
hinge broke.
3. Your firm failed 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 (21 CFR
211.165(a)).
You did not test all lots of your drug products for active
ingredient content prior to release. You also failed to conduct microbial
testing (i.e., total count, objectionable microorganisms) for each batch of
drug product you release.Your firm stated that your customer only requires
microbiological tests to be performed (b)(4). Because you lack
microbiological testing, there is insufficient assurance that the products you
distribute are safe and sanitary.
4. Your firm failed to prepare batch
production and control records with complete information relating to the
production and control of each batch of drug product produced (21 CFR 211.188).
Investigator requested batch records for OTC drug product lots
distributed to the United States, including (b)(4) Ointment and (b)(4).
You were unable to provide batch records.
In addition, analytical testing records were missing data,
dates, and signatures. Our investigator observed your staff altering
information in analytical test reports during the inspection. For example, you
significantly altered the analytical testing report for (b)(4) Ointment
lot (b)(4), although this lot had already been distributed to the
U.S. market.
CGMP consultant recommended
Based upon the nature of the violations FDA has been identified
at firm that and strongly recommend engaging consultants qualified as set forth
in 21 CFR 211.34, to assist the firm in meeting CGMP requirements. Use of
consultants does not relieve your firm’s obligation to comply with CGMP. However
firm executive management is remains responsible for fully resolving all
deficiencies and ensuring ongoing CGMP compliance.
Data Integrity Remediation
Firm’s quality system does not adequately ensure the accuracy
and integrity of data to support the safety, effectiveness, and quality of the
drugs you manufacture.
Source: FDA
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