Custom Research Labs Inc
Form 483 issued June 4, 2021 · GARDENA, California
- Inspection
- Jun 4, 2021
- Investigators
- Dogbeda F. Mackenzie· Jeffrey P. Raimondi
- Observations
- 10
- Pages
- 10
- FEI number
- 3008268262
In short: On June 4, 2021, FDA issued a Form 483 with 10 observations to Custom Research Labs Inc in GARDENA, California (FEI 3008268262) after an inspection that ran Jun 4, 2021. The investigators were Dogbeda F. Mackenzie and Jeffrey P. Raimondi. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.137 (expiration dating).
At a glance
Quality system and packaging & labeling account for 6 of 10 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
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
All records of production, control and components associated with a batch of drug product were not…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCustom Research Labs Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Custom Research Labs Inc?
FDA listed 10 observations on this Form 483, mostly about quality system, packaging & labeling and production. The most-cited regulation is 21 CFR 211.137 (expiration dating). The opening words of each observation are shown on this page.
Who inspected Custom Research Labs Inc?
Dogbeda F. Mackenzie and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Jun 4, 2021. Each investigator has a profile showing what they cite most.
When was Custom Research Labs Inc inspected by FDA?
The inspection ran Jun 4, 2021, and the Form 483 is dated June 4, 2021.
How do I get the full Form 483 for Custom Research Labs Inc?
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.