Accu Bio-Chem Laboratories
Form 483 issued August 31, 2021 · Glendale, California
- Inspection
- Aug 24 – Aug 31, 2021
- Investigators
- Alan L. Truong· Taichun Qin
- Observations
- 4
- Pages
- 5
- FEI number
- 3004876794
In short: On August 31, 2021, FDA issued a Form 483 with 4 observations to Accu Bio-Chem Laboratories in Glendale, California (FEI 3004876794) after an inspection that ran Aug 24 – Aug 31, 2021. The investigators were Alan L. Truong and Taichun Qin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Laboratory records do not include the initials or signature of (b) (4) showing that the original…
- 04
Verification of the suitability of the testing methods is deficient in that they are not documented…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmAccu Bio-Chem Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accu Bio-Chem Laboratories?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Accu Bio-Chem Laboratories?
Alan L. Truong and Taichun Qin are named on this Form 483, for the inspection of Aug 24 – Aug 31, 2021. Each investigator has a profile showing what they cite most.
When was Accu Bio-Chem Laboratories inspected by FDA?
The inspection ran Aug 24 – Aug 31, 2021, and the Form 483 is dated August 31, 2021.
How do I get the full Form 483 for Accu Bio-Chem Laboratories?
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.