Master Herbs, Inc
Form 483 issued September 14, 2020 · Pomona, California
- Inspection
- Sep 2 – Sep 14, 2020
- Investigator
- Uttaniti Limchumroon
- Observations
- 4
- Pages
- 5
- FEI number
- 3008916049
In short: On September 14, 2020, FDA issued a Form 483 with 4 observations to Master Herbs, Inc in Pomona, California (FEI 3008916049) after an inspection that ran Sep 2 – Sep 14, 2020. The investigator was Uttaniti Limchumroon. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility for approving or rejecting ding products manufactured, processed and packed…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees are not given training in the particular operations they perform as…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMaster Herbs, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Master Herbs, Inc?
FDA listed 4 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Master Herbs, Inc?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Sep 2 – Sep 14, 2020. Each investigator has a profile showing what they cite most.
When was Master Herbs, Inc inspected by FDA?
The inspection ran Sep 2 – Sep 14, 2020, and the Form 483 is dated September 14, 2020.
How do I get the full Form 483 for Master Herbs, 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.