Pharmaloz Manufacturing, Inc.
Form 483 issued June 21, 2018 · Lebanon, Pennsylvania
- Inspection
- Jun 19 – Jun 21, 2018
- Investigator
- Junho Pak
- Observations
- 6
- Pages
- 3
- FEI number
- 2523447
In short: On June 21, 2018, FDA issued a Form 483 with 6 observations to Pharmaloz Manufacturing, Inc. in Lebanon, Pennsylvania (FEI 2523447) after an inspection that ran Jun 19 – Jun 21, 2018. The investigator was Junho Pak. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.194(a)(4) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained ·discrepancy and a failure of a batch or any of its components…
- 02
Laboratory records do not include a complete record of all data secured in the course of…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training required to…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPharmaloz Manufacturing, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaloz Manufacturing, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Pharmaloz Manufacturing, Inc.?
Junho Pak is named on this Form 483, for the inspection of Jun 19 – Jun 21, 2018. Each investigator has a profile showing what they cite most.
When was Pharmaloz Manufacturing, Inc. inspected by FDA?
The inspection ran Jun 19 – Jun 21, 2018, and the Form 483 is dated June 21, 2018.
How do I get the full Form 483 for Pharmaloz Manufacturing, 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.