DLC Laboratories, Inc.
Form 483 issued January 31, 2025 · Paramount, California
- Inspection
- Jan 31, 2025
- Investigator
- Anney Lin
- Observations
- 1
- Pages
- 2
- FEI number
- 2020223
In short: On January 31, 2025, FDA issued a Form 483 with 1 observation to DLC Laboratories, Inc. in Paramount, California (FEI 2020223) after an inspection that ran Jan 31, 2025. The investigator was Anney Lin. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmDLC Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DLC Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected DLC Laboratories, Inc.?
Anney Lin is named on this Form 483, for the inspection of Jan 31, 2025. Each investigator has a profile showing what they cite most.
When was DLC Laboratories, Inc. inspected by FDA?
The inspection ran Jan 31, 2025, and the Form 483 is dated January 31, 2025.
How do I get the full Form 483 for DLC Laboratories, 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.