Drug factory · FDA FEI 3007432449

Technical Gas Products, Inc.

9 Avenue E, Hopkinton, MA, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 30, 2015.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Oxygen	Repackages it	Technical Gas Products, Inc.	65010-001, 65010-002

Ended	Result	Program	Problems noted
Apr 30, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	5

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include specimen of labeling.
No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into the failure of a batch or any of its components to meet specifications .
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed .
In-Process Material Area 21 CFR 211.42(c)(4)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules .

Registered with FDA for: repack.