Drug factory · FDA FEI 1000125324

PureTek Corporation

1145 Arroyo Ave Unit D, San Fernando, CA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 7, 2025 inspection

• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.

Jan 30, 2020 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Dec 15, 2017 inspection

• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Oct 27, 2015 inspection

• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.