Drug factory · FDA FEI 3006999064

Pierrel Spa

STRADA STATALE 7 APPIA 7 BIS 46/48, Capua, Italy

Problems found, fixed voluntarily at FDA's last inspection, Mar 23, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2009: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Articaine and Epinephrine	Makes it	Aira LLC, Burkhart Dental Supply Co., Inc, Safco Dental Supply Co.	87566-110, 87566-112, 43498-816 +3

FDA inspection history

Ended	Result	Program	Problems noted
Mar 23, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 15, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 26, 2018	No problems found	Drug Quality Assurance	—
Jun 6, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 5, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	8
Jul 31, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

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

Jun 6, 2014 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.
SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Records fail to include 21 CFR 211.122(c)
Records kept for each different labeling and packaging material shipment fail to include results of examination or testing.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.

Mar 5, 2012 inspection

Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning and maintenance are not included in individual equipment logs.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture.