H J Harkins Company Inc dba Pharma Pac
Form 483 issued March 3, 2023 · Grover Beach, California
- Inspection
- Feb 27 – Mar 3, 2023
- Investigator
- Gavin T. Cua
- Observations
- 4
- Pages
- 4
- FEI number
- 2024390
In short: On March 3, 2023, FDA issued a Form 483 with 4 observations to H J Harkins Company Inc dba Pharma Pac in Grover Beach, California (FEI 2024390) after an inspection that ran Feb 27 – Mar 3, 2023. The investigator was Gavin T. Cua. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is no written testing program designed to assess the stability…
- 03
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 04
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmH J Harkins Company Inc dba Pharma Pac history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at H J Harkins Company Inc dba Pharma Pac?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected H J Harkins Company Inc dba Pharma Pac?
Gavin T. Cua is named on this Form 483, for the inspection of Feb 27 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was H J Harkins Company Inc dba Pharma Pac inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
How do I get the full Form 483 for H J Harkins Company Inc dba Pharma Pac?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.